A STUDY ON PIRFENIDONE VERSUS NINTEDANIB IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS IN A TERTIARY CARE HOSPITAL: A CROSS SECTIONAL STUDY

Background: Idiopathic pulmonary fibrosis (IPF) is a chronic condition with a poor prognosis and have an average life expectancy of 3-4 years. Two antifibrotic treatments have been approved to treat IPF: nintedanib and pirfenidone. These medications lower the decline in lung function and lower the risk of acute respiratory deterioration, which is linked with a high morbidity and death.Individual clinical trials have not been powered to demonstrate mortality decreases, however analysis of pooled data from clinical trials and observational research imply that anti-fibrotic drugs increase life expectancy.

This study describes the utility of anti-fibrotic drugs and compare their efficacy.

Methods and Materials: This  6 month cross-sectional study conducted at Santhiram Medical College and General Hospital in Nandyal.In  patients with IPF , Clinical, functional and radiological data were gathered at baseline and during the follow-up, as per our Center procedure.This study compares and evaluates the efficacy of nintedanib and pirfenidone. A total of 40 patients over the age of 18 with IPF diagnosis were included. Patients under 18 years , those with known fibrosing lung diseases, bronchial asthma, COPD, HIV, Tuberculosis, or other organ failures were excluded.

Results: At baseline, IPF patients treated with Pirfenidone had Forced vital capacity(FVC) and Forced expiratory volume at 1 second(FEV1) predicted percentages of 63.57 Â± 8.34% and 72.31 Â± 4.91%, respectively. In IPF patients treated with Nintedanib, at baseline(time 0), FVC and FEV1 percentages were 60.15±8.82% and 72.31±4.91% respectively. There were no significant variations in FVC and FEV1 percentages at time 0 between patients treated with the two medications (p=0.23,p=0.7,respectively).

At 3-month follow-up, patients treated with Pirfenidone had predicted FVC and FEV1 values of 65.73 Â± 7.84% and 72.94 Â± 4.45%, respectively, whereas patients treated with Nintedanib had predicted valuesof 65.75 Â± 7.67% and 72.42 Â± 4.45%.

At 6-month follow-up, patients on Pirfenidone had predicted FVC and FEV1 values of 66.9 ± 8.72% and 73.5 ± 4.50%, respectively. Nintedanib treatment resulted in 67.7±8.46% and 72.94±4.51% outcomes.

Conclusion: our study shown that pirfenidone and nintedanib are equally effective at reducing FVC decline over a 6-month time frame.While nintedanib was slightly more beneficial in lowering FVC decline during the 6-month period. Both drugs were well tolerated, while nintedanib showing good tolerance in the majority of IPF patients.

背景：特发性肺纤维化（Idiopathic pulmonary fibrosis, IPF）是一种预后不良的慢性疾病，平均预期寿命为3~4年。目前已有两种抗纤维化疗法获批用于IPF治疗：尼达尼布（nintedanib）和吡非尼酮（pirfenidone）。此类药物可延缓肺功能下降，并降低急性呼吸恶化风险——该风险与较高的发病率和死亡率密切相关。单项临床试验的统计效力不足以证明其可降低死亡率，但对临床试验与观察性研究的合并数据分析显示，抗纤维化药物可延长患者预期寿命。

本研究旨在阐述抗纤维化药物的临床应用情况，并对比二者的疗效。

方法与材料：本研究为6个月横断面研究，于南迪亚尔的桑蒂拉姆医学院及综合医院开展。按照本中心的操作流程，我们在基线及随访期间收集了IPF患者的临床、功能及放射学数据。本研究对比并评估了尼达尼布与吡非尼酮的疗效。本研究共纳入40名年满18周岁、确诊为IPF的患者。排除标准包括：年龄不足18岁者、已知合并其他纤维化性肺疾病者、支气管哮喘患者、慢性阻塞性肺疾病（Chronic Obstructive Pulmonary Disease, COPD）患者、人类免疫缺陷病毒（Human Immunodeficiency Virus, HIV）感染者、肺结核患者及存在其他器官功能衰竭者。

结果：基线时，接受吡非尼酮治疗的IPF患者的用力肺活量（Forced vital capacity, FVC）占预计值百分比及第1秒用力呼气容积（Forced expiratory volume at 1 second, FEV1）占预计值百分比分别为63.57±8.34%与72.31±4.91%。接受尼达尼布治疗的患者在基线（时间0）时的FVC及FEV1占预计值百分比分别为60.15±8.82%与72.31±4.91%。两组患者在基线时的FVC与FEV1占预计值百分比均无显著差异（分别为p=0.23，p=0.7）。

在3个月随访时，吡非尼酮组患者的FVC及FEV1占预计值百分比分别为65.73±7.84%与72.94±4.45%，而尼达尼布组患者的对应值分别为65.75±7.67%与72.42±4.45%。

在6个月随访时，吡非尼酮组患者的FVC及FEV1占预计值百分比分别为66.9±8.72%与73.5±4.50%；尼达尼布组患者的对应值分别为67.7±8.46%与72.94±4.51%。

结论：本研究结果显示，在6个月的随访周期内，吡非尼酮与尼达尼布在延缓FVC下降方面疗效相当。不过在6个月期间，尼达尼布在延缓FVC下降方面略具优势。两种药物均具有良好的耐受性，其中尼达尼布在多数IPF患者中展现出了更优异的耐受性。